Genesis II
by Biosound, Inc. 510(k)
Active
510(k) K871697
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871697 | Date6 Nov 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DXK
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Genesis II is a Class II ultrasound system manufactured by Biosound, Inc. It is an echocardiograph device used in cardiovascular applications. The device operates at various frequencies including 2.5/5.0 MHz and 3.5 MHz with probe sizes of 16/19 mm.
The Genesis II is supplied as a single-use device and is not MRI compatible. It is stored at room temperature and has received FDA 510(k) clearance with K-number K871697 on November 6, 1987. The device is authorized under product code DXK and is regulated for cardiovascular use.
Other devices from Biosound, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the Genesis II device used for?
The Genesis II is an echocardiograph device designed for cardiovascular applications, providing ultrasound imaging at various frequencies including 2.5/5.0 MHz and 3.5 MHz with probe sizes of 16/19 mm.
Is the Genesis II reusable or single-use?
The Genesis II is supplied as a single-use device and is not intended for reuse. It should be discarded after a single procedure to ensure patient safety and device performance.
What are the storage requirements for the Genesis II?
The Genesis II should be stored at room temperature to maintain its integrity and functionality. Proper storage conditions help ensure the device performs as intended when used.
What regulatory approvals does the Genesis II have?
The Genesis II has received FDA 510(k) clearance with K-number K871697 on November 6, 1987. It is authorized under product code DXK and is regulated for cardiovascular use.